Specialty Pharma Journal Specialty, Precision & Technology
CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension (OLE) study …
Tag Archives: genzyme
December, 2017
October, 2017
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27 October
Data Suggests Slowing of Cortical Gray Matter Atrophy with Aubagio Delays Conversion to Clinically Definitive Multiple Sclerosis
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today new investigational data that suggest slowing of cortical gray matter volume loss (atrophy) with Aubagio® (teriflunomide) is associated with delayed conversion to clinically definite multiple sclerosis (CDMS). The data, from the Phase III TOPIC study in patients with …
September, 2017
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20 September
Alnylam’s Rare Disease Drug Meets Endpoints in Late-Stage hATTR Amyloidosis Study
CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint …
July, 2017
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7 July
Alnylam and Sanofi Genzyme Initiate Phase 3 Program of Investigational RNAi Therapeutic Fitusiran
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today the initiation of the ATLAS Phase 3 clinical program for fitusiran. The global, multicenter program is designed to evaluate the safety and efficacy of fitusiran in three separate …
April, 2017
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26 April
New Data from Genzyme’s Phase 3 Study Suggest Positive Effects of Aubagio on Cortical Gray Matter Atrophy
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that new investigational data evaluating the effect of Aubagio® (teriflunomide) on cortical gray matter atrophy in patients with a first clinical episode suggestive of MS will be presented at the 69th American Academy of Neurology (AAN) …
November, 2016
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14 November
Sanofi Genzyme to Co-Develop and Co-Commercialize Hemophilia Candidate with Alnylam
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company today announced that, pursuant to the companies’ global alliance signed in January 2014, Sanofi Genzyme elected to opt in to co-develop (through Sanofi R&D) and co-commercialize fitusiran, an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding …
June, 2015
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8 June
Breakthrough Status Granted to Genzyme’s Rare Enzyme Replacement Drug
Genzyme, a Sanofi company, recently announced that its investigational enzyme-replacement therapy was granted Breakthrough Therapy designation from US health regulators. The company said that the agency granted the status to its olipudase alfa for the treatment of patients with nonneurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick …
April, 2015
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29 April
Genzyme’s Fabry Disease Drug Granted FDA Fast Track Status
US health regulators have granted a speedy review for Genzyme’s investigational drug for treatment of a rare lysosomal storage disorder. Genzyme, a Sanofi company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of GZ/SAR402671, a new investigational oral substrate reduction therapy …
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23 April
Genzyme’s Lemtrada Slows Brain Atrophy in Multiple Sclerosis Extension Study
Today, Sanofi’s Genzyme announced its multiple sclerosis (MS) drug Lemtrada slowed brain atrophy in an extension study of a Phase III trial. The company announced new magnetic resonance imaging (MRI) data from the Lemtrada (alemtuzumab) clinical development program will be presented at the American Academy of Neurology (AAN) Annual Meeting. …
February, 2015
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18 February
Genzyme Provides Postmarket Study Results for its Gaucher Disease Drug
Sanofi’s Genzyme recently announced that treatment with its Cerdelga (eliglustat) reduced spleen size 28 percent compared to placebo in patients with Gaucher disease. The company announced that results from the ENGAGE registration study evaluating Cerdelga in treatment-naïve patients with Gaucher disease type 1 were published in The Journal of the …